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GeneCentric Therapeutics Acquires Select ImmunoGenomics

On August 15, 2019 GeneCentric Therapeutics, Inc. reported that it has acquired Select ImmunoGenomics, LLC, a Chapel Hill, NC-based provider of advanced immunogenomic, data analysis and biomarker development services to support the development of immuno-oncology drugs (Press release, GeneCentric Therapeutics, AUG 15, 2019, View Source [SID1234538790]). The acquisition provides the combined company with a comprehensive, integrated set of RNA-based solutions to enhance drug development by identifying the right patients for oncology drugs, improving response rates and durability, and ultimately patient outcomes. Financial terms were not disclosed.

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"There is growing recognition that many factors beyond gene mutations contribute to drug response, including gene expression, activation, and signaling pathways as well as adaptive and innate immune status," said Dr. Myla Lai-Goldman, founder and Executive Chair of GeneCentric. "Integration of both companies’ technologies will uniquely allow us to capture the complexity of tumor biology in predictive response signatures to accelerate and add value to our partners’ drug development programs."

Select ImmunoGenomics was founded by two University of North Carolina researchers, Benjamin Vincent, MD, an expert in computational immune-genomics, and Joel Parker, PhD, a genomics and data science expert. The company supported clients at research as well as at diagnostics and drug development organizations. Drs. Vincent and Parker will serve as advisors to GeneCentric.

"GeneCentric’s strengths in bioinformatics and RNA-based informatics are a natural fit with our immuno-therapeutics’ focus." Said Dr. Benjamin Vincent, co-Founder of Select ImmunoGenomics. "While immunotherapy has revolutionized cancer care, a majority of patients still do not benefit. A huge challenge in the field is identifying which drugs will benefit which patients. Our computational genomics and systems biology approaches converge to address this challenge, as well as to apply genomics to develop more effective cancer therapies."

"By joining Drs. Vincent and Parker’s technology platform to GeneCentric’s, the ability to advance predictive therapeutic response gene signatures grows substantially," said Dr. Michael Milburn, CEO & President of GeneCentric Therapeutics, Inc. "The combined technologies will create a wealth of opportunities for the company going forward."

City of Hope Now Enrolling Patients for First-in-Human T Cell Trial for HPV-Associated Cancers

On August 15, 2019 City of Hope reported that the first-in-human, phase 1 T cell trial for patients who have human papillomavirus (HPV)-associated cancers that have relapsed, or are resistant to treatment, is now open at City of Hope (Press release, City of Hope, AUG 15, 2019, View Source [SID1234538789]). The institution is the first to open such a trial on the West Coast.

The research trial, which is sponsored by Kite, a Gilead Company, targets HPV-associated cancers with the HPV type 16, a strain which causes about 70% of all cervical cancers worldwide, as well as oropharyngeal, anal, penile and vaginal cancers.

Nearly 88,000 HPV-associated cancers will be diagnosed this year in the United States, and the American Cancer Society estimates that more than 19,500 deaths will occur due to HPV-associated cancers.

"Early stage HPV-associated cancers are quite treatable, but the story is different when the cancer returns or is resistant to treatment," said Erminia Massarelli, M.D., Ph.D., M.S., City of Hope associate clinical professor in the Department of Medical Oncology & Therapeutics Research. "These patients currently have few treatment options so we are hopeful that T cell therapy will work."

T cells play a central role in the immune system by destroying diseased cells, including tumor cells, throughout the body. For the trial, a person’s own T cells will be collected and genetically engineered in a laboratory with KITE-439, an E7 T-cell receptor. The receptor is designed to target antigens expressed in the cancer cells that are infected by HPV, potentially inducing T cell activation against the cells. Patients will receive a single dose of KITE-439.

Patients who join the trial must be HLA-A*02:01 positive, relapsed or refractory after at least one line of therapy, and meet other inclusion criteria. Patients also receive high-dose chemotherapy prior to receiving the T cells; the chemotherapy makes "space" in a person’s immune system for the genetically engineered cells to engraft and mediate an anti-cancer effect. The T cell therapy is investigational, and the trial will test if it is safe and efficacious.

"City of Hope continues to lead the way in advancing CAR T and T cell therapies across a range of blood and solid tumor cancers," said Stephen J. Forman, M.D., City of Hope’s Francis & Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation and leader of the Hematologic Malignancies and Stem Cell Transplantation Institute. "City of Hope pursues its own CAR T and T cell technology in active preclinical and clinical programs, and also works with other academic researchers and biopharmaceutical companies to make innovative therapies available to more patients."

Patients interested in more trial information can click here. The trial is part of City of Hope’s T Cell Therapeutics Research Laboratory, which currently has 20 T cell and CAR T clinical trials.

GT Medical Technologies Announces Completion of First Case in Arizona to Use GammaTile Therapy

On August 15, 2019 HonorHealth Scottsdale Osborn Medical Center is the first hospital in Arizona to begin offering GammaTile Therapy, a new approach to treating recurrent brain tumors (Press release, GT Medical Technologies, AUG 15, 2019, View Source [SID1234538788]). GammaTile Therapy is an FDA-cleared, surgically targeted radiation therapy (STaRT) that is designed to delay tumor regrowth for patients with all types of recurrent brain tumors. The first patient was treated by John Wanebo, M.D., a neurosurgeon and an independent member of the HonorHealth medical staff.

"The first patient I was able to treat with GammaTile Therapy had a very large, aggressive meningioma that has recurred several times," Dr. Wanebo said. "I am pleased to be able to offer this patient GammaTile Therapy – a treatment proven to delay brain tumor recurrence and improve quality of life. This therapy was developed with patients like this in mind, and I am hopeful that it will make a meaningful difference."

Data supporting the efficacy and safety profile of the therapy for patients with recurrent, previously treated meningiomas were published earlier this year in the Journal of Neurosurgery (JNS), the official journal of the American Association of Neurological Surgeons. Clinical data from other types of tumors, including gliomas, glioblastomas and metastases, were presented at the AANS Annual Scientific Meeting in April.

Aggressive brain tumors tend to be resistant to current treatments and nearly always recur. Outcomes for patients with brain tumors have improved very little over the past 30 years. GammaTile consists of a bioresorbable, conformable 3D-collagen tile embedded with a Cesium radiation source. GammaTile is placed at the time of surgery so that it immediately begins to target residual tumor cells with radiation while limiting the impact on healthy brain tissue.

GammaTile Therapy offers some advantages over other treatments for patients undergoing surgery for recurrent brain tumors. A course of External Beam Radiation Therapy (EBRT), for example, requires daily treatments for up to six weeks; in contrast, patients treated with GammaTile Therapy require no additional trips to the hospital or clinic. Additionally, many patients may not be candidates for EBRT at the time of tumor recurrence because the risk of additional EBRT outweighs the potential benefits. Finally, those patients who may be candidates for EBRT typically have to wait several weeks for surgical wound healing before beginning treatment, allowing residual tumor cells to replicate during this waiting period.

"We are thrilled to see GammaTile Therapy offered in Arizona – our home state, and the place where our co-founders first developed this therapy," said Matt Likens, president and CEO of GT MedTech. "Many patients with recurrent brain tumors have run out of options. Through the elegantly simple approach of GammaTile Therapy, we hope to create a new standard of care for these patients. Our purpose is to improve the lives of patients with brain tumors, and we are excited to continue delivering on this purpose by expanding the availability of GammaTile Therapy across the U.S."

NOXXON Announces Completion of €1 Million Capital Increase

On August 15, 2019 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that the previously announced capital increase of €1 million through a private placement of shares without warrants (see press release of August 6, 2019) has been completed and that further investment is already committed for a future investment round (Press release, NOXXON, AUG 15, 2019, View Source [SID1234538786]).

"We are pleased to announce the completion of the capital increase, which has placed NOXXON in a solid position that will facilitate the advancement and initiation of the Phase 1/2 clinical trial in brain cancer. We are working at full speed to open the clinical trial sites in Germany where the trial has already been approved by the regulatory authorities and Ethics Committees. In parallel, we are in active discussions regarding additional financing, industry partnerships and M&A," said Aram Mangasarian, CEO of NOXXON.

Trovagene to Present New Data from Onvansertib Phase 2 Study in Metastatic Castration-Resistant Prostate Cancer at Asia-Pacific Prostate Cancer Conference

On August 15, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company, developing drugs that target cell division (mitosis), for the treatment of various cancers, including prostate, colorectal and leukemia, reported that new clinical data from its Phase 2 trial of onvansertib, in combination with Zytiga (abiraterone acetate)/prednisone, in metastatic Castration-Resistant Prostate Cancer (mCRPC), will be presented as an oral poster at the 20th Asia-Pacific Prostate Cancer Conference, which will be held August 23-26 in Melbourne, Australia (Press release, Trovagene, AUG 15, 2019, View Source [SID1234538785]).

The data will be presented in an oral, moderated poster session on Saturday, August 24, 2019 at 1:00 pm (AEDT)

Details of the Trovagene Poster Presentation are as follows:

Title: A Phase 2 Study of the Combination of PLK1 Inhibitor, Onvansertib, with Abiraterone and Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Abstract Number: 1044

Moderated Poster Session: Clinical Urology

Location: Goldfields Exhibition